PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind
non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000
UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material
removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic
surgeries for femoral neck and trochanteric fractures, THR, TKR)
Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24
hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization,
patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started
6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH
injection if needed for the intended treatment duration of 2 to 12 weeks based on medical
judgment (according to immobilization). Patients allocated to the comparator arm will receive
enoxaparin once daily for the same intended treatment duration. All patients will have a
30-day observational period after cessation of treatment.